The following data is part of a premarket notification filed by Trend Scientific, Inc. with the FDA for Trend Giardia Direct Detection Rs Test System.
| Device ID | K953284 |
| 510k Number | K953284 |
| Device Name: | TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM |
| Classification | Giardia Spp. |
| Applicant | TREND SCIENTIFIC, INC. 368 WEST COUNTY RD. D New Brighton, MN 55112 |
| Contact | Mariellyn Truax |
| Correspondent | Mariellyn Truax TREND SCIENTIFIC, INC. 368 WEST COUNTY RD. D New Brighton, MN 55112 |
| Product Code | MHI |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-13 |
| Decision Date | 1995-10-06 |